PhotoPharmics Submits FDA Application for Parkinson’s Disease Therapy

510K De Novo Pathway Key to Market Authorization for Company’s Innovative Medical Device

July 16, 2018, Salt Lake City, UT— PhotoPharmics announced today that its De Novo request to the FDA has been accepted for review of the company’s Spectramax™ specialized phototherapy medical device for treating Parkinson’s disease.

“This is an exciting milestone in our company’s history,” said Dan Adams, Science Officer for PhotoPharmics. “We met with the FDA earlier this year to discuss the results of our pivotal clinical trial which paved the way for our submission. This is the culmination of several years of planning, regulatory and quality system execution, clinical trial design and management, data collection and statistical analysis.”

“It is exciting to be at this stage as a company,” said Kent Savage, CEO of PhotoPharmics. “We have accomplished a great deal with the support of some of the most capable movement disorder, regulatory, quality, legal, and statistical teams in the country. Our positive clinical data combined with the non-risk nature of our device means we’re optimistic about market authorization in the coming months.”

The De Novo pathway is available to organizations that can show low to moderate risk for their medical device, and where no  predicate device has been cleared by the FDA. If approved, Spectramax specific bandwidth phototherapy could be the first treatment for Parkinson’s disease which offers symptomatic relief without significant side effects.

About PhotoPharmics

PhotoPharmics is a privately-held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative disorders through the eyes. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms for seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).

Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patients’ lives by delivering safe and effective treatments. Learn more at www.photopharmics.com.

PhotoPharmics Completes Pivotal Phototherapy Clinical Trial for Parkinson’s Disease

Double-Blind Trial Demonstrates Safety and Efficacy of Spectramax™ Medical Device

February 1, 2018, Salt Lake City, UT—PhotoPharmics completed a multinational double-blind, randomized clinical trial of its pivotal Spectramax™ medical device to demonstrate safety and efficacy of the company’s specific bandwidth phototherapy for overall improvement in Parkinson’s disease.

“Completing this clinical investigation is a major milestone for us—and for Parkinson’s disease patients,” said Kent Savage, CEO of PhotoPharmics. “To our knowledge, this is the first study of its kind to suggest a large, clinically meaningful benefit on top of other Parkinson’s disease therapies.”

“We were able to study the long-term effects of specific bandwidth light therapy for people with Parkinson’s disease,” said Savage. “Our findings show promise for patients hoping to improve their condition, especially with non-motor symptoms where options are so limited. Because of this trial, we now better understand the effects of wavelengths, intensities, and time of day of light administration—to be included in our patented technology we call Spectramax.”

The company’s Spectramax clinical trial device demonstrated that specific light wavelengths are convenient and safe. Participants in the clinical trial primarily used the device by sitting at a table or desk with the device in front of them illuminating their faces. They were able to watch TV, read, eat, and socialize while receiving their light treatment.

“Improving the quality of life and minimizing side effects are important objectives for people with Parkinson’s disease, and we are very close to finding solutions!” said Dan Adams, Science Officer at PhotoPharmics. “Unlike many Parkinson’s disease investigations, which measure potential benefits for patients after their standard dopaminergic therapy has worn off, we measured patients in their best or ‘ON’ state to see if we could deliver any improvement. We saw a strong signal for motor performance, but we were even more surprised with the significant non-motor improvement and the large improvements on quality of life.”

This multi-center, multi-national, randomized, double-masked, controlled, parallel‑group, trial involved 92 patients and established the safety and efficacy of Spectramax phototherapy for motor and non-motor symptoms in Parkinson’s disease. The trial was conducted at the Massachusetts General Hospital, Boston; Vrije Universiteit Medical Center, Amsterdam; Aspen Clinical Research, Salt Lake City.

PhotoPharmics will present the results from this study at the 2018 Movement Disorders Society’s annual meeting (Hong-Kong, October 5-9, 2018).

Additional details regarding the trial can be found on the Michael J Fox Trial Finder (https://foxtrialfinder.michaeljfox.org/trial/3870/) and clinicaltrials.gov (#NCT02175472).

About PhotoPharmics

PhotoPharmics is a privately-held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative disorders through the eyes. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms for seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).

Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patients’ lives by delivering safe and effective treatments. Learn more at www.photopharmics.com.